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510(k) K071527

PNEUPAC VR1 AIR MIX by Smiths Medical International , Ltd. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2007
Date Received
June 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Smiths Medical International , Ltd.

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  • K060945 — PORTEX PERCUTANEOUS TRACHEOSTOMY KIT (June 19, 2006)
  • K051322 — PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS (August 5, 2005)

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